PATIENT INFORMATION LEAFLET

1 VITAMIN B COMPOUND STRONG

Tablets BPC

Read all of this leaflet carefully because it contains important information for you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must consult your doctor if your symptoms worsen or do not improve.

If you notice any side effects not mentioned in this leaflet or if you experience one of the side effects listed as serious, please inform your doctor or pharmacist.

In this leaflet:

1.    What Vitamin B Compound Strong Tablets BPC are and what they are used for

2.    Before you take Vitamin B Compound Strong Tablets BPC

3.    How to take Vitamin B Compound Strong Tablets BPC

4.    Possible side effects

5.    How to store Vitamin B Compound Strong Tablets BPC

The active substances in your tablets are thiamine hydrochloride 5mg, riboflavine 2mg, nicotinamide 20mg and pyridoxine hydrochloride 2mg. The other ingredients are lactose, maize starch, magnesium stearate, shellac, gelatin, syrup, Nipasept sodium (containing sodium ethylhydroxybenzoate (E215), sodium propylhydroxybenzoate (E217) and sodium methylhydroxybenzoate (E219)), talc, sucrose, heavy kaolin, titanium dioxide (E171) and opalux brown colouring (contaning sucrose, iron oxides (E172), propylhydroxybenzoate (E216), methylhydroxybenzoate (E218) and sodium benzoate (E211)).

Vitamin B Compound Strong Tablets BPC are brown, sugar coated, deep convex tablets.

This medicine is available in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1000 tablets. Not all the pack sizes are marketed.

Product Licence Holder and manufacturer:

Crescent Pharma Limited, Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED.

1.    WHAT VITAMIN B COMPOUND STRONG TABLETS BPC ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Vitamin B Compound Strong Tablets BPC. The active ingredients are thiamine hydrochloride 5mg, riboflavine 2mg, nicotinamide 20mg and pyridoxine hydrochloride 2mg.

The active ingredients belong to a group of medicines known as the vitamin B group. These are used for the treatment of mild chronic vitamin B deficiency.

2.    BEFORE YOU TAKE VITAMIN B COMPOUND STRONG TABLETS BPC

Do not take Vitamin B Compound Strong Tablets BPC and tell your doctor or pharmacist if you:

•    are allergic to thiamine hydrochloride, riboflavine, nicotinamide, pyridoxine hydrochloride or any of the other ingredients of the tablets.

Take special care with Vitamin B Compound Strong Tablets BPC if you:

•    are undergoing the following laboratory tests - urinary catecholamine concentration measurement by fluorimetric method, or urinobilinogen determination using Erlich's reagent,

•    are taking levodopa to treat Parkinson's disease or parkinsonism, as one of this medicine's ingredients, pyridoxine, will reverse the effects of levodopa (this is not a problem if you are taking levodopa in combination with carbidopa).

Check with your doctor to make sure this medicine is right for you.

Taking other medicines with Vitamin B Compound Strong Tablets BPC:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. This is particularly important if you are taking:

•    antidepressants such as imipramine, amitriptyline or doxepine hydrochloride,

•    phenothiazines (used for mental illness such as chlorpromazine and promethiazine and also used for vomiting and allergies)

•    probenecid (used for gout)

•    chloramphenicol (antibiotic)

•    antibacterials used in the treatment of tuberculosis such as cycloserine, isoniazid and ethionamide,

•    hydralazine (used to reduce blood pressure),

•    penicillamine (used in the treatment of Wilson's disease and heavy metal poisoning),

•    immunosuppressants such as chlorambucil, colchicine and dimethyl sulphoxide,

•    oestrogens (used in menopausal disorders).

Alcohol:

Avoid alcohol while taking this medicine.

Pregnancy and breast feeding:

Consult your doctor before taking this medicine if you are pregnant or breast feeding.

Driving and using machines:

This medicine should not affect your ability to perform skilled tasks such as driving or operating machinery. However, if you think you are affected do not drive or operate machinery.

Important information about an ingredient of Vitamin B Compound Strong Tablets BPC:

Contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Contains Nipasept and Opalux brown colouring. These contain hydroxybenzoate esters which may cause allergic reactions (possibly delayed).

3.    HOW TO TAKE VITAMIN B COMPOUND STRONG TABLETS BPC

Swallow the tablets with water.

Dose: adults, elderly and children over 12 years:

1 or 2 tablets three times a day.

Children under 12 years:

Not recommended.

If you have been prescribed these tablets, your doctor will decide the dose that is best for you. The pharmacist's label will tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.

If you forget to take Vitamin B Compound Strong Tablets BPC:

If you miss a dose of this medicine, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue as normal. DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR FORGOTTEN INDIVIDUAL DOSES.

If you take more Vitamin B Compound Strong Tablets BPC than you should:

If you or anyone else takes too much of this medicine, contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the container so the medicine can be identified.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Vitamin B Compound Strong Tablets BPC can cause side effects.

Although side effects are rare with this medicine, allergic reactions (hypersensitivity) such as skin rash, itching or wheeziness may occur. Large doses may cause discoloured urine. Long-term administration of large doses can cause nervous disorders.

If you notice any side effects not mentioned in this leaflet or if you experience one of the listed side effects as serious, please inform your doctor or pharmacist.

5.    HOW TO STORE VITAMIN B COMPOUND STRONG TABLETS BPC

Store the medicine in a place protected from heat, light and moisture.

Keep these tablets in safe place where children cannot see or reach them. These tablets could harm them.

Do not take the tablets after the expiry date which is stated on the carton.

Do not take the tablets if you notice any signs of deterioration such as chipped or broken or discoloured tablets. This leaflet was last approved in June 2006.